FDA Approvals of Brand-Name Prescription Drugs in 2015

2016 Oncology Pharmacy Guide to New FDA Approvals - Annual Novel Pharmaceuticals

 

The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories:

I. New Pharmaceuticals: New Molecular Entities and New Biologic License Applications
II. New Combinations and New Indications
III. New Formulations
IV. New Biosimilars and New Viral Therapies


I. New Pharmaceuticals: New Molecular Entities and New Biologic License Applications

Alecensa (NME)
(Alectinib; Genentech)
Class/route: ALK inhibitor; oral
Indication: For the treatment of patients with ALK-positive metastatic NSCLC who have progressed while receiving crizotinib or are intolerant to it
Approval considerations: Accelerated approval, breakthrough therapy, orphan drug, priority review

Cotellic (NME)
(Cobimetinib; Genentech)
Class/route: Mitogen-activated protein kinase inhibitor/extracellular signal 306 regulated kinase 1 and 2 inhibitor; oral
Indication: For the treatment of unresectable or metastatic melanoma, in combination with vemurafenib, in patients with a BRAF V600E or BRAF V600K mutation
Approval considerations: Fast track, orphan drug, priority review

Darzalex (BLA)
(Daratumumab; Janssen Biotech)
Class/route: First-in-class human CD38-directed monoclonal antibody; intravenous
Indication: For the treatment of patients with multiple myeloma who have received at least 3 previous lines of therapy including a proteasome inhibitor and an immunomodulatory agent and for those whose disease is double­-refractory to a proteasome inhibitor and to an immunomodulatory agent
Approval considerations: Accelerated approval, breakthrough therapy, fast track, orphan drug, priority review

Empliciti (BLA)
(Elotuzumab; Bristol-Myers Squibb)
Class/route: First-in-class SLAMF7-directed immunostimulatory antibody; intravenous infusion
Indication: For the treatment, in combination with lenalidomide and dexamethasone, of patients with multiple myeloma who have received 1 to 3 previous therapies
Approval considerations: Breakthrough therapy, orphan drug, priority review

Farydak (NME)
(Panobinostat; Novartis)
Class/route: Histone deacetylase inhibitor; oral
Indication: For the treatment, in combination with bortez­omib and dexamethasone, of patients with multiple myeloma who have received at least 2 previous regimens, including bortezomib and an immunomodulatory agent
Approval considerations: Accelerated approval, orphan drug, priority review, REMS program

Ibrance (NME)
(Palbociclib; Pfizer)
Class/route: First-in-class CDK 4 + CDK 6 inhibitor; oral
Indication: For the treatment, in combination with letrozole, of postmenopausal women with metastatic, estrogen receptor–positive, HER2-negative breast cancer as initial endocrine-based therapy
Approval considerations: Accelerated approval, breakthrough therapy, priority review

Lenvima (NME)
(Lenvatinib; Eisai)
Class/route: Receptor TKI; oral
Indication: Treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer
Approval considerations: Orphan drug, priority review

Lonsurf (NME)
(Trifluridine and tipiracil; Taiho Oncology)
Class/route: Nucleoside metabolic inhibitor and thymidine phosphorylase inhibitor; oral
Indication: Treatment of metastatic colorectal cancer in patients who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biologic therapy, and if RAS wild-type, an anti-EGFR therapy
Approval consideration: Fast track

Ninlaro (NME)
(Ixazomib; Takeda Pharmaceuticals)
Class/route: Proteasome inhibitor; (first) oral
Indication: For the treatment, in combination with lenalidomide and dexamethasone, of patients with multiple myeloma who have received at least 1 previous therapy
Approval considerations: Orphan drug, priority review

Odomzo (NME)
(Sonidegib; Novartis)
Class/route: Hedgehog pathway inhibitor; oral
Indication: For the treatment of adults with locally advanced basal-cell carcinoma that has recurred after surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy

Portrazza (BLA)
(Necitumumab; Eli Lilly)
Class/route: EGFR antagonist; intravenous infusion
Indication: For the first-line treatment, in combination with gemcitabine and cisplatin, of patients with metastatic squamous NSCLC
Approval considerations: Fast track, orphan drug

Tagrisso (NME)
(Osimertinib; AstraZeneca)
Class/route: EGFR kinase inhibitor; oral
Indication: For the treatment of metastatic EGFR T790M mutation–positive NSCLC (as detected by an FDA-approved test) whose disease progressed while or after receiving EGFR TKI therapy
Approval considerations: Accelerated approval, breakthrough therapy, fast track, orphan drug, priority review

Unituxin (BLA)
(Dinutuximab; United Therapeutics)
Class/route: First-in-class GD2-binding monoclonal antibody; intravenous infusion
Indication: For the treatment, in combination with granulocyte-macrophage colony-stimulating factor, IL-2, and 13-cis-retinoic acid, of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to previous first-line multiagent, multimodality therapy
Approval considerations: Orphan drug, priority review

Varubi (NME)
(Rolapitant; Tesaro)
Class/route: Substance P/neurokinin 1 receptor antagonist; oral
Indication: For the prevention, in combination with other antiemetic agents, of delayed nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy for cancer, including, but not limited to, highly emetogenic chemotherapy

Yondelis (NME)
(Trabectedin; Janssen Products)
Class/route: Alkylating drug; intravenous infusion
Indication: For the treatment of unresectable or metastatic liposarcoma or leiomyosarcoma in patients who received a previous anthracycline-­containing regimen
Approval considerations: Orphan drug, priority review

ALK indicates anaplastic lymphoma kinase; BLA, biologic license application; CDK, cyclin-dependent kinase; EGFR, epidermal growth factor receptor; FDA, US Food and Drug Administration; IL, interleukin; NME, new molecular entity; NSCLC, non–small-cell lung cancer; REMS, Risk Evaluation and Mitigation Strategy; TKI, tyrosine kinase inhibitor; VEGF, vascular endothelial growth factor.

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II. New Combinations and New Indications

Cyramza (new indication)
(Ramucirumab; Eli Lilly)
Class/route: Human VEGF receptor-2 antagonist; intravenous
New indication: For the treatment, in combination with FOLFIRI, of metastatic colorectal cancer in patients whose disease progressed during or after previous therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine
Existing indications: As a single agent or in combination with paclitaxel for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma in patients with disease progression during or after previous fluoropyrimidine- or platinum-containing chemotherapy; in combination with docetaxel, for the treatment of metastatic NSCLC in patients whose disease progressed during or after platinum­-based chemotherapy

Emend (new indications)
(Aprepitant; Merck)
Class/route: Substance P/neurokinin 1 receptor antagonist; oral
New indications: In combination with other antiemetic agents, in patients aged ≥12 years and in patients aged <12 years who weigh ≥30 kg for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy; for the treatment of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy
Existing indications: In adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy; for the treatment of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy; for the prevention of postoperative nausea and vomiting in adults

Imbruvica (new indication)
(Ibrutinib; Janssen Biotech)
Class/route: Bruton’s TKI; oral
New indication: First drug approved for the treatment of patients with Waldenström’s macroglobulinemia
Existing indications: For the treatment of CLL in patients who have received at least 1 previous therapy; for the treatment of mantle-cell lymphoma in patients who have received at least 1 previous therapy; for the treatment of patients with CLL with 17p deletion

Iressa (new indication)
(Gefitinib; AstraZeneca)
Class/route: TKI; oral
New indication: For the first-line treatment of metastatic NSCLC in patients whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test
Existing indication: For the third-line treatment of advanced NSCLC after nonresponse to chemotherapy

Keytruda (new indications)
(Pembrolizumab; Merck)
Class/route: PD-1–blocking antibody; intravenous infusion
New indications: For the treatment of metastatic NSCLC in patients whose tumors express PD-L1 as determined by a genetic diagnostic test, and whose disease progressed with or after platinum-based chemotherapy; for the first-line treatment of unresectable or metastatic melanoma
Existing indication: For the treatment of unresectable or metastatic melanoma
Approval consideration: Accelerated approval

Kyprolis (new indication)
(Carfilzomib; Amgen)
Class/route: Proteasome inhibitor; intravenous infusion
New indication: In combination with lenalidomide and dexamethasone, for the treatment of multiple myeloma in patients who received 1 to 3 previous lines of therapy
Existing indication: As monotherapy for relapsed or refractory multiple myeloma in patients who received at least 2 previous therapies, including bortezomib and an immunomodulatory agent, and whose disease progressed during or within 60 days after completing the previous therapy

Lonsurf (new combination)
See NMEs/BLAs listing

Opdivo (new indications)
(Nivolumab; Bristol-Myers Squibb)
Class/route: PD-1–blocking antibody; intravenous infusion
New indications: For the treatment of metastatic squamous NSCLC that progressed with or after platinum-­based chemotherapy; metastatic NSCLC that progressed with or after platinum-based chemotherapy; and advanced renal-cell carcinoma in patients who received previous antiangiogenic therapy
Existing indications: For the treatment of BRAF V600 mutation–positive unresectable or metastatic melanoma, as a single agent; and for the treatment of unresectable or metastatic melanoma and disease progression after ipilimumab therapy, and, if BRAF V600 mutation positive, a BRAF inhibitor
Approval considerations: Accelerated approval, breakthrough therapy, fast track, priority review

Opdivo plus Yervoy (new combination)
(Nivolumab and ipilimumab; Bristol-Myers Squibb)
Classes/route: PD-1–blocking antibody and human CTLA-4–blocking antibody; intravenous
Indication: In combination with ipilimumab as a treatment for patients with BRAF V600 wild-type and BRAF V600 mutation–positive unresectable or metastatic melanoma; in January 2016, the FDA approved an expanded indication to include patients with advanced melanoma, regardless of their BRAF mutational status
Approval consideration: Accelerated approval

Pomalyst (new indication)
(Pomalidomide; Celgene)
Class/route: Thalidomide analog; oral
New indication: In combination with dexamethasone, for the treatment of patients with multiple myeloma who have received at least 2 previous therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of their last therapy
Existing indication: For the treatment of patients with multiple myeloma who have received at least 2 previous therapies, including lenalidomide and bortezomib, and whose disease progressed during or within 60 days of completion of their last therapy
Approval considerations: Orphan drug, REMS program

Revlimid (new indication)
(Lenalidomide; Celgene)
Class/route: Thalidomide analog; oral
New indication: For the first-line treatment, in combination with dexamethasone, of all patients with multiple myeloma, including newly diagnosed patients
Existing indications: For the treatment of multiple myeloma, in combination with dexamethasone, in patients who have received at least 1 previous therapy; for the treatment of patients with transfusion-dependent anemia resulting from low- or intermediate-1–risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; for the treatment of patients with mantle-cell lymphoma that has relapsed or progressed after 2 previous therapies, ­including bortezomib
Approval consideration: REMS program

Vistogard (new indication)
(Uridine triacetate; Wellstat Therapeutics)
Class/route: Pyrimidine analog; oral
New indications: For the emergency treatment of adults and pediatric patients after a fluorouracil or a capecita­bine overdose regardless of symptoms; for the emergency treatment of adults and pediatric patients who exhibit early-onset, severe, or life-threatening toxicity affecting the cardiac or central nervous system and/or early-onset, unusually severe adverse reactions within 96 hours after receiving fluorouracil or capecitabine therapy
Existing indication: For use as an antidote in the treatment of 5-fluorouracil poisoning
Approval considerations: Fast track, orphan drug, priority review

Yervoy (new indications; new combination)
(Ipilimumab; Bristol-Myers Squibb)
Class/route: Human CTLA-4–blocking antibody; intravenous
New indications: For the adjuvant treatment of patients with cutaneous melanoma and pathologic involvement of regional lymph nodes of >1 mm who have undergone complete resection, including total lymphadenectomy; and as adjuvant therapy for patients with stage III melanoma, to lower the risk for melanoma recurrence after surgery
New combination: See listing for Opdivo plus Yervoy
Existing indication: For the treatment of unresectable or metastatic melanoma
Approval consideration: Accelerated approval

BLA indicates biologic license application; CLL, chronic lymphocytic leukemia; CTLA-4, cytotoxic T-lymphocyte antigen 4; EGFR, epidermal growth factor receptor; FDA, US Food and Drug Administration; FOLFIRI, folinic acid, fluorouracil, irinotecan; NME, new molecular entity; NSCLC, non–small-cell lung cancer; PD-1, programmed death receptor-1; PD-L1, PD ligand 1; REMS, Risk Evaluation and Mitigation Strategy; TKI, tyrosine kinase inhibitor; VEGF, vascular endothelial growth factor.

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III. New Formulations

Bendeka (new formulation)
(Bendamustine hydrochloride; Teva/Eagle Pharmaceuticals)
Class/route: Alkylating drug; intravenous infusion
New formulation: A liquid, low-volume (50-mL), short-­infusion-time (10-minute) formulation
Existing formulation: 500-mL admixture in a 60-minute intravenous infusion
Indication: For the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen

Onivyde (new formulation)
(Irinotecan liposome injection; Merrimack Pharmaceuticals)
Class/route: Topoisomerase inhibitor; intravenous injection
New formulation: Encapsulated irinotecan in a liposomal formulation
Existing formulation: Irinotecan hydrochloride injection
Indication: In combination with leucovorin and 5-fluorouracil, for the treatment of advanced or metastatic pancreatic cancer that progressed after gemcitabine-based chemotherapy
Approval considerations: Priority review, orphan drug

Onsolis (new formulation)
(Fentanyl buccal soluble film; BioDelivery Sciences)
Class/route: Opioid agonist; buccal
New formulation: Fade-proof pink color
Indication: For the management of breakthrough pain in patients with cancer aged ≥18 years who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain
Approval consideration: REMS program

REMS indicates Risk Evaluation and Mitigation Strategy.

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IV. New Biosimilars and New Viral Therapies

Imlygic (new viral therapy)
(Talimogene laherparepvec; Amgen)
Class/route: First genetically modified oncolytic viral therapy; intralesional injection
Indication: For the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with recurrent melanoma after initial surgery

Zarxio (new biosimilar)
(filgrastim-sndz; Sandoz/Novartis)
Class/routes: Leukocyte growth factor; subcutaneous, intravenous
New biosimilar: Biosimilar (of reference drug Neupogen): first-ever biosimilar approved in the United States
Indications: To decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever; for reducing the time to neutrophil recovery and the duration of fever after induction or consolidation chemotherapy in patients with acute myeloid leukemia; to reduce the duration of neutropenia and neutropenia-related clinical sequelae in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; for long-term administration to reduce the incidence and duration of neutropenia sequelae in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia

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Related Items
FDA Approvals of Brand-Name Prescription Drugs in 2016
2017 Oncology Pharmacy Guide to New FDA Approvals published on May 4, 2017 in Annual Novel Pharmaceuticals
Last modified: May 18, 2016